【目的】 探讨平肝胶囊（由龙胆、夏枯草、生地黄、天麻、栀子、车前草6味中药组成）治疗肝阳上亢型高血压合并焦虑 抑郁患者临床疗效及相关影响因素。【方法】 选取2022年1月~2023年1月在广东省第二中医院诊断为肝阳上亢型高血压合并 焦虑抑郁患者150例，采用随机数字表法将患者随机分为试验组和对照组，每组各75例。对照组给予常规药物治疗（苯磺酸 氨氯地平片加氯沙坦钾片），试验组在对照组的基础上给予平肝胶囊治疗，疗程为8周。观察2组患者治疗前后血压、焦虑 自评量表（SAS）、抑郁自评量表（SDS）、世界卫生组织生活质量测定简表（WHO-QOL-BREF）各领域评分的变化情况，评价 2组患者的降压疗效、中医证候疗效及用药安全性，并分析影响平肝胶囊疗效的主要因素。【结果】（1）脱落情况方面，治疗 期间，试验组脱落 6 例，对照组脱落 4 例，最终共有 140 例患者完成全部疗程的治疗，其中试验组 69 例、对照组 71 例。 （2）降压疗效方面，治疗 8周后，试验组的总有效率为 89.86%（62/69），对照组为 64.79%（46/71），组间比较（χ2检验），试验 组的降压疗效明显优于对照组（P＜0.05）。（3）中医证候疗效方面，治疗8周后，试验组的总有效率为92.75%（64/69），对照组 为66.20%（47/71），组间比较（χ2 检验），试验组的中医证候疗效明显优于对照组（P＜0.05）。（4）血压监测方面，治疗后，2组 患者的收缩压和舒张压均较治疗前改善（P＜0.05），且试验组的改善幅度均明显优于对照组（P＜0.05）。（5）生活质量方面，治 疗后，2 组患者 WHO-QOL-BREF 量表的生活领域、心理领域、社会关系领域与环境领域等各项参数均较治疗前明显改善 （P＜0.05），且试验组的改善幅度均明显优于对照组（P＜0.05）。（6）焦虑、抑郁方面，治疗后，2组患者的SAS、SDS评分均较治疗前明显改善（P＜0.05），且试验组的改善幅度均明显优于对照组（P＜0.05）。（7）安全性方面，治疗期间，2组患者均无明 显不良反应发生，具有较高的安全性。（8）影响因素方面，桑基图及对应分析发现，＜65岁、男性、高血压1级、轻度焦虑、 轻度抑郁患者的降压幅度及证候改善更为明显（P＜0.05）。【结论】 平肝胶囊治疗肝阳上亢型高血压合并焦虑抑郁患者的临床 疗效显著。

Objective To investigate the clinical efficacy of Pinggan Capsules（composed of six Chinese herbs，i. e. Gentianae Radix et Rhizoma， Prunellae Spica， Rehmanniae Radix， Gastrodiae Rhizoma， Gardeniae Fructus and Plantaginis Herba） in treating patients with hypertension complicated with anxiety and depression of liver-yang hyperactivity type， and to explore the related influencing factors of efficacy. Methods A total of 150 patients diagnosed as hypertension complicated with anxiety and depression of liver-yang hyperactivity type treated at Guangdong Second Traditional Chinese Medicine Hospital from January 2022 to January 2023 were enrolled. The patients were randomly divided into the trial group and the control group using a random number table， with 75 cases in each group. The control group received conventional medicine treatment （Amlodipine Besylate Tablets plus Losartan Potassium Tablets），while the trial group received Pinggan Capsules in addition to the conventional treatment. The treatment for the two groups lasted for 8 weeks. Before and after treatment，the changes in blood pressure，Self-Rating Anxiety Scale （SAS） scores，Self-Rating Depression Scale （SDS） scores，and scores of each domain of World Health Organization Quality of Life-BREF （WHO-QOL-BREF） were observed in the two groups. Antihypertensive efficacy， TCM syndrome efficacy， and drug safety in the two groups were evaluated， and the main factors influencing the efficacy of Pinggan Capsules were analyzed. Results （1） During the treatment period，6 cases dropped out from the trial group and 4 cases dropped out from the control group. A total of 140 patients completed the full course of treatment， including 69 in the trial group and 71 in the control group.（2） After 8 weeks of treatment，the total effective rate for antihypertensive efficacy in the trial group was 89.86%（62/69）， significantly higher than that in the control group [64.79% （46/71）]. The intergroup （tested by chi-square test） showed that the antihypertensive efficacy of the trial group was significantly superior to that of the control group （P＜0.05）.（3） After 8 weeks of treatment，the total effective rate for TCM syndrome efficacy in the trial group was 92.75%（64/69），significantly higher than that in the control group [66.20%（47/71）]. The intergroup （tested by chi-square test） showed that the TCM syndrome efficacy of the trial group was significantly superior to that of the control group（P＜0.05）.（4） After treatment，systolic blood pressure and diastolic blood pressure were improved in both groups compared to those before treatment（P＜0.05）， and the improvement in the trial group was significantly superior to that in the control group（P＜0.05）.（5）After treatment， the scores of all domains （physical，psychological，social relationships，and environmental） of WHO-QOL-BREF scale were significantly improved in both groups compared to those before treatment （P＜0.05），and the improvement in the trial group was significantly superior to in the control group（P＜0.05）.（6） After treatment， SAS and SDS scores were significantly improved in both groups compared to those before treatment （P＜0.05），and the improvement in the trial group was significantly superior to that in the control group （P＜0.05）.（7） No significant adverse reactions occurred in either group during the treatment period， indicating high safety. （8）Sankey diagram and correspondence analysis showed that patients aged＜65 years，male，grade 1 hypertension，mild anxiety，and mild depression achieved significant hypotensive effect and symptom-relief effect （P＜0.05）. Conclusion Pinggan Capsules have significant clinical efficacy in treating hypertension complicated with anxiety and depression of liveryang hyperactivity type and is worthy of clinical promotion and application.

R259.441

广东省中医药局科研项目（编号：202106081715414980）